NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II –Budget & Research Plan
Canadian Collaborating Clinical Trials Network
G. Canadian Collaborating Clinical Trials Network Application
The budget and research plan for this component are essentially the same as for the Network Group
Operations Center and associated Statistics and Data Management Centers s (Operations Center and
SDMC) although the volume of clinical trials, accrual, and collaborations would be expected to be
more limited. In addition, the Canadian partner would be expected to establish relationships with
U.S. Network Group Operations Centers to provide appropriate regulatory oversight for U.S.
Networks trials conducted in Canada when needed and this budget component should be explained
and justified in the application budget.
1. Detailed Budget for the Initial Budget Period
Applicants for the Canadian Collaborating Clinical Trials Network should prepare their budgets
following the budget section for the Network Group Operations Center provided in Part 2 –
Section II.B.1. of these Guidelines and the budget section for the Network Group Statistics and
Data Management Center provided in Part 2 – Section II.C.1. of these Guidelines, with
appropriate adjustments.
2. Research Plan
In the “Research Plan” section of the Canadian Collaborating Clinical Trials Network ‘s
application, a Specific Aims page should be provided as well as separate PHS 398 Research
Strategy Sections for the 5 sub-sections listed below within the corresponding specified page
limits (and the Table of Contents for the Research Plan section of the application should be
modified accordingly). The 5 sub-sections listed below consist of an Operations Center Overview
and 4 required functional components of an Operations Center & SDMC - i.e., (1) Clinical Trial
Development & Member Site Accrual Program, (2) Operational Management, (3) Statistics
Analysis Program and Data Management, and (4) Program for Collaborations and Participation in
Collective Management).
Table of Contents for the Network Group Operations Center application only
Specific Aims (including Impact Statement) - 1 page
Research Strategy Section for the Canadian Collaborating Clinical Trials Network Application
This section must consist of the sub-sections A-E described below.
A. Operations, Statistics, and Data Management Center Overview - 6 pages
B. Clinical Trial Development & Member Site Accrual Program- 12 pages
C. Operational Management – 12 pages
D. Statistics Analysis Program and Data Management - 12 pages
E. Program for Collaborations and Participation in Collective Management - 12 pages
Other sections of the PHS 398 Research Plan (398 application instructions Part I, Section 5.5),
such as the sections for Letters of Support (e.g., Letter of Support from the institution or
organization sponsoring the Network Groups Operations Center) and Multiple Program
Director/Principal Investigator (PD(s)/PI(s) Leadership Plan, remain unmodified and must be
completed following standard instructions.
2.1 Sub-section A. Operations, Statistics, and Data Management Center Overview (up to 6
pages)
This sub-section should provide a general overview of the Operations, Statistics, and Data
Management Center of the Canadian Collaborating Clinical Trials Network organization and
describe the general features and operations of the organization. The applicant should
provide a diagram illustrating the organizational structure of the organization in this sub-
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